MHRA-100062-PIP01-21-M01 (update)

Key Facts

Active Substance
  • VANZACAFTOR CALCIUM DIHYDRATE
  • TEZACAFTOR
  • DEUTIVACAFTOR
Invented Name
alyftrek
PIP Number MHRA-100062-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
Therapeutic area
Therapeutic area:
  • Pneumology - Allergology
Conditions / Indications
Conditions / Indications:
  • Treatment of Cystic Fibrosis
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-100062-PIP01-21-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):VANZACAFTOR CALCIUM DIHYDRATETEZACAFTORDEUTIVACAFTOR.pdf
Published Date 11/08/2026